OXCARBAZEPINE (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

NDC 60429-061-05

Oxcarbazepine
Tablets, USP

150 mg

PHARMACIST: DISPENSE THE ACCOMPANYING
MEDICATION GUIDE TO EACH PATIENT.

Rx only 500 Tablets

PRINCIPAL DISPLAY PANEL — 300 mg Tablet Bottle Label

NDC 60429-062-05

Oxcarbazepine
Tablets, USP

300 mg

PHARMACIST: DISPENSE THE ACCOMPANYING
MEDICATION GUIDE TO EACH PATIENT.

Rx only 500 Tablets

PRINCIPAL DISPLAY PANEL — 600 mg Tablet Bottle Label

NDC 60429-063-05

Oxcarbazepine
Tablets, USP

600 mg

PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT.

500 Tablets

OXCARBAZEPINE oxcarbazepine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-063(NDC:51991-294) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 600 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 2 POLYVINYL ALCOHOL, UNSPECIFIED ALUMINUM OXIDE LECITHIN, SOYBEAN TALC

Product Characteristics Color brown (Beige) Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code B294 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60429-063-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:60429-063-05 500 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078069 01/11/2008

OXCARBAZEPINE oxcarbazepine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-061(NDC:51991-292) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 150 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 2 POLYVINYL ALCOHOL, UNSPECIFIED ALUMINUM OXIDE LECITHIN, SOYBEAN TALC

Product Characteristics Color brown (Beige) Score 2 pieces Shape OVAL Size 11mm Flavor Imprint Code B292 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60429-061-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:60429-061-05 500 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078069 01/11/2008

OXCARBAZEPINE oxcarbazepine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-062(NDC:51991-293) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXCARBAZEPINE (OXCARBAZEPINE) OXCARBAZEPINE 300 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 2 POLYVINYL ALCOHOL, UNSPECIFIED ALUMINUM OXIDE LECITHIN, SOYBEAN TALC

Product Characteristics Color brown (Beige) Score 2 pieces Shape OVAL Size 15mm Flavor Imprint Code B293 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60429-062-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:60429-062-05 500 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:60429-062-18 180 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078069 01/11/2008

Labeler — Golden State Medical Supply, Inc. (603184490)

Establishment
Name	Address	ID/FEI	Operations
Golden State Medical Supply, Inc.		603184490	relabel (60429-061), repack (60429-061), relabel (60429-062), repack (60429-062), relabel (60429-063), repack (60429-063)

Revised: 06/2021 Golden State Medical Supply, Inc.